Status
Ongoing
Drug Enforcement D-0369-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Classification
Class II
Report Date
March 20, 2024
Termination Date
—
Product Information
- Product description
- Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-060-01.
- Product quantity
- 7,488 bottles
- Reason for recall
- CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Address
-
2 Independence Way, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0369-2024
- Event ID
- 94142
- Recall initiation date
- March 4, 2024
- Center classification date
- March 8, 2024
- Code info
- Lot #: DNE0894A, Exp 07/31/2025
- More code info
- —